Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209339
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2005-09-13
Brief Title:
Feasibility Study of a Percutaneous Mitral Valve Repair System
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy EVEREST I
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVERESTI
Brief Summary:
Prospective multi-center Phase I study of the Evalve Cardiovascular Valve Repair System CVRS in the treatment of mitral valve regurgitation Patients will undergo 30-day 6 month 12 month and 5 year clinical follow-up
Detailed Description:
Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System
The study is a prospective multi-center Phase I study of the Evalve Cardiovascular Valve Repair System CVRS in the treatment of mitral valve regurgitation A minimum of 20 patients will be enrolled an additional maximum of 12 roll in-patients a maximum of 2 per site may be enrolled and analyzed separately Patients will undergo 30-day 6 month and 12 month clinical follow-up
Up to 12 clinical sites throughout the US may participate
The primary endpoint is acute safety at thirty days with a secondary efficacy endpoint of reduction of MR
The study is a prospective multi-center Phase I study of the Evalve Cardiovascular Valve Repair System CVRS in the treatment of mitral valve regurgitation A minimum of 20 patients will be enrolled an additional maximum of 12 roll in-patients a maximum of 2 per site may be enrolled and analyzed separately Patients will undergo 30-day 6 month and 12 month clinical follow-up
Up to 12 clinical sites throughout the US may participate
The primary endpoint is acute safety at thirty days with a secondary efficacy endpoint of reduction of MR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol 0301 | None | None | None |